Impact of Consuming Plant Sterols on Endothelial Function and Blood Pressure

N

National University of Singapore

Status

Completed

Conditions

Endothelial Dysfunction
Cardiovascular Diseases
Diet Modification
Metabolic Syndrome

Treatments

Dietary Supplement: plant sterols
Other: healthy diet

Study type

Interventional

Funder types

Other

Identifiers

NCT03723330
S6

Details and patient eligibility

About

The purpose of the research is to assess the impact of co-consuming plant sterols-enriched food product as part of a healthy eating pattern diet on endothelial function (brachial artery FMD, vasodilation-related and vasoconstriction-related biomarkers) and blood pressure management (24-hour ambulatory and classic blood pressure) in Singapore individuals with MetS.

Full description

This is a 13-wk double-blinded, randomized, crossover study design. Following a 1-wk pre-intervention baseline period, subjects will be randomly assigned to follow a healthy eating pattern diet either contain 2.0 g free plant sterols equivalent of their palmityl esters (Plant Sterol Diet) or do not contain plant sterols (Control Diet) for 4 weeks. After a 4-week dietary 'washout' period, they will consume the alternative diet for 4 weeks. The random assignment will be done with SAS 9.4 software. Body size measurement, dietary assessment, brachial artery FMD and blood pressure measurements, and fasting-state blood collection will be conducted at week 1, 5, 9, and 13, which correspond to before and during the last 1 week of the two 4-week intervention periods. During study week 1 and weeks 6-9, all subjects will consume their habitual, unrestricted self-chosen diets. During study weeks 2-5 and 10-13, all subject will follow a healthy eating pattern diet, referred to as the "My Healthy Plate" designed by HPB. Each subject's energy requirement will be estimated using sex-specific equations and Recommended Dietary Allowances for healthy Singaporean. One-on-one dietary counselling and written instructions for each subject will be provided by a research dietitian and trained research staff to achieve a healthy eating pattern diet. Compliance with the plant sterols consumption will be promoted by frequent online and in-person contact.

Enrollment

20 patients

Sex

All

Ages

35+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Ability to give an informed consent;
  • Age>35 years old;
  • Meet any 3 of the 5 following NCEP-ATP III MetS criteria (waist circumference > 90 cm (male), > 80 cm (female); fasting glucose concentration ≥ 100 mg/dL or on medication; triglyceride ≥ 150 mg/dL or on medication; high density lipoprotein cholesterol (HDL) < 40 mg/dL (male), < 50 mg/dL (female); systolic or diastolic blood pressure > 130/80 mmHg or on medication);
  • Weight change < 3kg in the past 3 months;
  • No exercising vigorously over the past 3 months;
  • No allergy to plant sterols; no acute illness; not smoking;
  • No drinking more than 2 alcoholic drinks per day;
  • No pregnant, lactating, or planning pregnancy in the next 6 months.

Exclusion criteria

  • Unable to give an informed consent;
  • Age<35 years old;
  • Meet less than 3 of following NCEP-ATP III MetS criteria (waist circumference > 90 cm (male), > 80 cm (female); fasting glucose concentration ≥ 100 mg/dL or on medication; triglyceride ≥ 150 mg/dL or on medication; high density lipoprotein cholesterol (HDL) < 40 mg/dL (male), < 50 mg/dL (female); systolic or diastolic blood pressure > 130/80 mmHg or on medication);
  • Weight change > 3kg in the past 3 months;
  • Exercise vigorously over the past 3 months;
  • Allergy to plant sterols; no acute illness; not smoking;
  • Drinking more than 2 alcoholic drinks per day;
  • Pregnant, lactate, or plan pregnancy in the next 6 months.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

20 participants in 2 patient groups

Plant sterol with a healthy diet
Experimental group
Description:
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided with specific instructions to consume plant sterols-enriched food (contains 2 g plant sterols).
Treatment:
Other: healthy diet
Dietary Supplement: plant sterols
Healthy diet
Active Comparator group
Description:
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.
Treatment:
Other: healthy diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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